The Cxbladder Monitoring Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

803 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-04

Study Completion Date

2016-09-23

Brief Summary

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The aim of this trial is to determine the performance characteristics of the Cxbladder test for the detection of recurrent urothelial carcinoma (UC) in patients with a recent history of urinary tract UC, who have been treated according to standard practice and are undergoing routine investigative cystoscopy.

The gold standard for determination of clinical truth is cystoscopy, plus any follow up investigations relating to the current visit.

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Detailed Description

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Conditions

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Urothelial Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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UC monitoring patients

Patients undergoing investigative cystoscopy for the detection of urothelial carcinoma as part of a standard-of-care schedule of investigations.

All patients will have urine samples taken and analyzed for NMP22 ELISA, NMP22 BladderChek, urine cytology and Cxbladder.

No results for any tests under evaluation in this study are provided to the clinician for diagnostic purposes.

Cxbladder

Intervention Type OTHER

Cxbladder is a non invasive UC detection test measuring five messenger RNA (mRNA) biomarkers present at elevated levels in patients presenting with urothelial carcinoma.

Interventions

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Cxbladder

Cxbladder is a non invasive UC detection test measuring five messenger RNA (mRNA) biomarkers present at elevated levels in patients presenting with urothelial carcinoma.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Confirmed positive diagnosis for primary or recurrent urinary tract UC over the past 2 years.
* Patient is undergoing investigative cystoscopies for the monitoring of recurrence of UC at intervals prescribed by a clinical practitioner
* Patient is 18 years of age or older.

Exclusion Criteria

* Prior genitourinary manipulation (cystoscopy / catheterisation / dilation) in the 14 days before urine collection, current urinary tract infection, current or known history of urinary tract inflammatory disorder, recent history of glomerulonephritis, nephrosis or other renal inflammatory disorders, recent history of pyelonephritis
* Patient has undergone total bladder cystectomy as treatment for bladder UC

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No